A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD) [M15-741]

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease [M15-741]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224809

Enrollment

Registered

2019-07-30

Start date

2019-08-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

investigational material(s) Generic name etc : ABBV-951 INN of investigational material : - Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive - Subjects must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion criteria

Exclusion criteria: - Subject is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study. - Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Design outcomes

Primary

Measure	Time frame
safety -Adverse Events [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ] Treatment emergent adverse events defined as any adverse event from the initiation of CSCI through 30 days after last infusion device is removed -Adverse Events of Special Interest [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ] Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed -Percentage of subjects with numeric grade equal to or higher than 5 and with letter grade equal to or higher than D on the Infusion Site Evaluation Scale [ Time Frame: up to 52 weeks ] -Clinical laboratory test data : Change from Baseline to end of study [ Time Frame: up to 52 weeks ] -Vital Signs: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] -Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [ Time Frame: up to 52 weeks ] ECG recordings will be evaluated as 'normal' or 'abnormal'	—

Measure

Time frame

safety -Adverse Events [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ] Treatment emergent adverse events defined as any adverse event from the initiation of CSCI through 30 days after last infusion device is removed -Adverse Events of Special Interest [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ] Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed -Percentage of subjects with numeric grade equal to or higher than 5 and with letter grade equal to or higher than D on the Infusion Site Evaluation Scale [ Time Frame: up to 52 weeks ] -Clinical laboratory test data : Change from Baseline to end of study [ Time Frame: up to 52 weeks ] -Vital Signs: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] -Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [ Time Frame: up to 52 weeks ] ECG recordings will be evaluated as 'normal' or 'abnormal'

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Secondary

Measure	Time frame
efficacy -Average normalized daily "Off" time and "On" times: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary. -Parkinson's Disease (PD) symptoms: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available). -Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study [ Time Frame: up to 52 weeks ] The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires. -Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study [ Time Frame: up to 52 weeks ] The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD. -Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study [ Time Frame: up to 52 weeks ] The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.	—

Measure

Time frame

efficacy -Average normalized daily "Off" time and "On" times: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary. -Parkinson's Disease (PD) symptoms: Change from Baseline to end of study [ Time Frame: up to 52 weeks ] PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available). -Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study [ Time Frame: up to 52 weeks ] The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires. -Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study [ Time Frame: up to 52 weeks ] The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD. -Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study [ Time Frame: up to 52 weeks ] The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.

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Countries

Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026